Asthma severe
Formoterol for asthma: Evidence of serious adverse effects Public release date: 7-Oct-2008
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Contact: Jennifer Beal
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Wiley-Blackwell
Formoterol for asthma: Evidence of serious adverse effects
Asthma sufferers who regularly take the beta2-agonist formoterol are more likely to suffer non-fatal serious adverse events than those given placebos. A review carried out by Cochrane Researchers showed a significantly increased risk for people who took the drug once or twice daily for at least 12 weeks.
Long-acting beta2-agonists are inhaled to help open the airways and last for 12 hours or more, but their long-term use is controversial
reported pharmacokinetic (PK) and safety data from a Phase I trial of its Aerovant inhalation powder that demonstrate good tolerability with no evidence of local irritancy following asthma patients' inhalation of a single 10 mg dose.
This 10 mg dose will be the highest of three doses investigated in Aerovance's Phase IIb dose-ranging study, which is scheduled to begin early next year. Evidence gathered from nonclinical and clinical studies indicates the primary action of Aerovant is local to the lung, while the PK data confirm that the dry powder inhaler achieved the targeted lung dose. The data were presented by E. Burmeister Getz, Ph.D, at the European Respiratory Society (ERS) Annual Congress in Berlin.
'We are encouraged by the PK and safety data that demonstrate Aerovant's potential for treating uncontrolled asthma when delivered as an inhalation powder,' said Mark Perry, Aerovance's president and chief executive officer. 'The conclusions presented, along with our efficacy and safety data from previous clinical studies, validate the benefits of delivering Aerovant directly to the lung. Similar to the most widely used asthma medications, Aerovant will be delivered as a dry powder, a method of administration that doctors and asthma patients have embraced.'
Ten subjects with mild-to-moderate asthma participated in the study and were administered a single 10 mg dose of Aerovant inhalation powder via the EZ Aer(TM) Inhaler
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